This application claims priority under 35 U.S.C. xc2xa7365(c) based on the PCT Application No. PCT/DE98/03285, filed Nov. 10, 1998 and having a priority date of Nov. 11, 1997 based on German Patent Application No. 197 49 741.1.
This invention relates to the field of percutaneous endoscopic gastrostomy (PEG) and, in particular, attaching a percutaneously applied flexible line or tube to the skin.
The problem of fixating a PEG tube or line in position on a patient""s skin is well known in the art. A typical solution is disclosed in WO 94/08648. This device is primarily used during a percutaneous endoscopic gastrostomy (PEG) and serves as fixation device for a percutaneous catheter. During a percutaneous endoscopic gastrostomy, as described in DE 9112338U1, a cannula is inserted into the stomach through a hole that is placed in the abdominal wall. A suture is then thread through the cannula. Using an endoscope, the end of the suture is grasped and guided up through the patient""s mouth. The suture is then attached to the flexible line or tube and the tube is guided down through the esophagus into the stomach and out through the abdominal incision where the flexible line leaves percutaneously. One end of the line is attached to the inner abdominal wall of the stomach. The flexible line or cannula serves for example as catheter for enteral feeding.
To avoid unintentional movement, a fixation device is required at the outside of the abdominal wall. A typical fixation device is disclosed in WO 94/08648 comprising a covering plate with a hole for the flexible line that is attached to the patient""s abdominal wall. On top of the cover plate, there is a supporting plate with an open channel on its edge having in its cross section the shape of a semicircle. In the first area, the channel runs vertically to the cover plate, and after bending in the second area, it runs parallel to the cover plate. The result achieved is that the flexible line leaves the patient""s body vertically but is then rerouted parallel to the skin surface. The cover plate in both mentioned areas has solidly affixed mechanisms that close the channel""s aperture and constitute eyelets through which the flexible line has to pass.
However, one difficulty in using the above-mentioned fixation device as well as other prior art devices is that during the process of inserting the flexible line into the fixation device, the flexible line changes diameter. A fixation device that does not cause the diameter of the flexible to appreciably change, provides a simple insertion of the flexible line and an easy way to move it to for adaptation to the individual situation, can operated single handedly, and enables the fixation of the flexible line in a 90xc2x0 angle without the flexible line becoming crimped or bent is not found in the prior art.
The invention comprises a fixation device that presses the flexible line into a supporting wall having a channel, and a pivotally hinged securing mechanism (barrel-vault shaped body) to secure the flexible line that is flexibly attached to the cover plate. The hole for the passage of the flexible line is located between the barrel-vault shaped body""s axis and the supporting wall. Therefore, the barrel-vault shaped body can be turned in the direction of the flexible line. If it is open, the flexible line passes through the cover plate directly. In closing, the barrel-vault shaped body takes hold of the flexible line and bends it onto the supporting plate""s surface. With the barrel-vault shaped body open, the cover plate can be easily moved and adjusted, whereas the flexible line is fixed if the barrel-vault shaped body is closed. The fixation happens solely by using the tension in the flexible line material; consequently, its diameter remains substantively unchanged. The flexible line does not crimp or bend. This is important to guarantee an optimal and undisturbed flow of liquid through the flexible line. Another feature of the invention is the one-hand-operability of the fixation mechanism. The cover plate can easily be moved with the open barrel-vault shaped body and the fixation mechanism can be closed and locked by using only one hand.
The invention is preferably equipped with a cover plate made of soft and elastic material, while the barrel-vault shaped body is made of a stiff material. A cover plate made of soft and elastic material enables a tactile comfortable application to the patient""s skin and can be used as fixation mechanism to arrest the barrel-vault shaped body at the same time.
Preferably, the barrel-vault shaped body comprises a preformed channel, that together with the channel on the supporting plate forms a cross section with the shape of a circle that covers the flexible line and keeps it in shape. This securely prevents the flexible line from being bent even if the flexible line is being pulled.
The cover plate preferably is made in a triangular shape and, at the side of the supporting wall, has triangular wings. The hole for the passage of the flexible line preferably is located close to the center of this triangle, allowing an even dispersion of pressure and avoiding local concentrated pressure. This means an optimal wearing comfort that is important because the fixation mechanism can be utilized together with a catheter for long-term enteral feeding; hence, it can be used for long periods of time. Additionally there is the possibility of plaster fixation.
Another part of the invention is a gastrostomy-set that comprises a flexible line with a retaining element and a fixation mechanism. The barrel-vault shaped body and the flexible line are attuned in a way that prevents the flexible line from being crimped or bent and keeps its tubular shape from compressing.
These aspects of the invention are not meant to be exclusive and other features, aspects, and advantages of the present invention will be readily apparent to those of ordinary skill in the art when read in conjunction with the following description, appended claims and accompanying drawings.